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Contoura Vision

Contoura Vision is a topography-guided laser-assisted () procedure designed to correct refractive errors such as and by creating a highly personalized treatment map of the patient's . Developed by Laboratories, Inc., it utilizes the WaveLight EX500 System and Allegretto Wave Eye-Q System to perform precise corneal based on detailed topographic data. Approved by the U.S. on November 21, 2016, for patients aged 18 and older with stable , it is indicated for reducing spherical equivalent up to -6.0 diopters with up to -3.0 diopters. The core technology of Contoura Vision involves scanning the with a topographer that captures over 22,000 unique elevation points, far exceeding the approximately 200 points used in traditional wavefront-guided , to identify and address subtle irregularities in corneal shape. This mapping allows the laser to smooth peaks and valleys on the corneal surface, not only correcting the prescription but also enhancing overall visual quality by minimizing higher-order aberrations that can cause symptoms like halos, glare, and reduced . In the pivotal FDA involving 314 eyes, efficacy was demonstrated by 93.3% of eyes achieving a manifest refraction spherical equivalent (MRSE) within ±0.5 diopters of the intended target at six months postoperatively, with 99.7% within ±1.0 diopter. Safety outcomes from the same trial were robust, with 100% of eyes maintaining or gaining lines of best spectacle-corrected (BSCVA) and no eyes experiencing a loss of two or more lines or worse than 20/40 at six months; the cumulative rate of serious ocular adverse events was 0.9%. Additionally, 93% of treated eyes achieved uncorrected (UCVA) of 20/20 or better, surpassing typical benchmarks for standard procedures. These results position Contoura Vision as one of the most advanced and precise options for correction available, with high patient satisfaction rates reported in clinical use.

Background

History and Development

Contoura Vision originated in the early 2000s as an evolution of laser-assisted () techniques, addressing key limitations of -guided technology, which primarily focused on higher-order aberrations but often fell short in correcting lower-order irregularities and corneal surface variations. Topography-guided approaches emerged to enable detailed mapping of up to 22,000 corneal elevation points, offering a more comprehensive customization for refractive correction compared to the roughly 200 points measured by wavefront systems. Alcon advanced this technology through its Wavelight platform, acquired in 2007, integrating topography-guided ablation software with systems for enhanced precision in treating and . Key contributions came from collaborations with researchers like Dr. John Kanellopoulos, whose studies on topography-guided since the mid-2000s demonstrated improved visual outcomes in irregular corneas, influencing the refinement of treatment algorithms. A pivotal milestone occurred on November 21, 2016, when the U.S. Food and Drug Administration (FDA) granted premarket approval for the Wavelight EX500 system equipped with Contoura Vision software, expanding access to topography-guided for patients with up to -6.0 diopters and up to -3.0 diopters. This approval was supported by clinical trials across multiple U.S. sites involving 374 eyes, where 92.6% achieved uncorrected (UCVA) of 20/20 or better at three months postoperatively. In March 2025, the FDA further expanded the indications via PMA supplement S043 to include up to -9.0 diopters (spherical equivalent > -1.00 D to ≤ -9.00 D) while maintaining the astigmatism limit of up to -3.0 diopters. Following FDA approval, Contoura Vision gained rapid international adoption by 2017, with implementations in and Asia through Alcon's global distribution, and subsequent software updates in 2020 enabled enhanced retreatment options for residual refractive errors while maintaining safety profiles.

Overview and Indications

Contoura Vision is a topography-guided laser-assisted () procedure that customizes corneal reshaping based on detailed topographic mapping of the eye's surface to address refractive errors such as and . This approach utilizes advanced imaging to create a personalized pattern, differing from standard by incorporating over 22,000 data points from the to optimize visual outcomes. The primary indications for Contoura Vision include the correction of nearsightedness () up to -9.0 diopters (D) (as of the 2025 FDA expansion) and up to 3.0 D. It is also indicated for treating subtle corneal irregularities resulting from prior , where standard methods may fall short. The U.S. (FDA) approved this topography-guided application in 2016 for eligible patients seeking to reduce dependence on or contacts, with expansions in 2025. The target population consists of adults aged 18 years or older with stable refractive prescriptions, typically showing no more than 0.5 change over the past year, and overall healthy eyes free from active disease. These individuals often pursue the procedure to achieve spectacle independence while benefiting from enhanced visual quality. A key unique aspect of Contoura Vision is its ability to address subtle corneal irregularities overlooked by conventional wavefront-guided or standard , thereby reducing higher-order aberrations and potentially improving by minimizing symptoms like halos and .

Procedure

Patient Eligibility and Preparation

Patient eligibility for Contoura Vision, a topography-guided procedure, requires candidates to be at least 18 years of age with a stable manifest , defined as less than 0.5 diopters change in or and less than 0.25 diopters in axis over at least 12 months prior to surgery. Suitable patients typically have spherical equivalent greater than -1.00 diopters up to -9.00 diopters, with up to -8.00 diopters spherical component and no more than 3.00 diopters of , adequate corneal thickness (generally at least 480 microns centrally to ensure sufficient residual stromal bed post-ablation), and no evidence of advanced such as . Contraindications include or , diagnosed collagen vascular, autoimmune, or immunodeficiency disorders, or suspicious , history of ocular , recent ocular injury or surgery within six months, ischemic heart disease or other serious systemic conditions, uncontrolled , severe , or large pupils (exceeding 7 mm in low-light conditions), which may increase the risk of symptoms such as halos and glare. Patients taking medications such as or hydrochloride are also excluded due to potential impacts on corneal healing. Preoperative preparation begins with a comprehensive ocular examination, including to measure thickness, topography mapping to assess surface irregularities, ensuring the cornea is suitable for personalized planning. wear must be discontinued prior to evaluation—typically two to four weeks for soft lenses and three to four weeks for rigid gas permeable lenses—to allow corneal shape recovery and accurate measurements. is obtained, detailing potential risks such as dry eyes, halos, or under/over-correction, with emphasis on realistic outcomes. Notably, FDA approval trials for Contoura Vision excluded patients with prior corneal to focus on virgin corneas, though enhancements may be considered in select post-LASIK cases.

Surgical Technique

The Contoura Vision surgical technique is a topography-guided variant of that customizes corneal reshaping based on detailed preoperative topographic mapping to address both refractive errors and subtle corneal irregularities. Performed in a sterile operating environment, the procedure integrates advanced laser systems for precision and safety, typically utilizing bladeless technology to minimize risks associated with mechanical instruments. The overall process emphasizes alignment accuracy to ensure the treatment profile matches the patient's unique corneal . The procedure commences with the creation of a corneal flap, usually employing a femtosecond laser such as the FS200, resulting in a flap thickness of 100 to 120 microns to preserve adequate stromal bed depth. This flap is gently lifted to expose the underlying corneal . Next, the individualized —previously generated from multiple high-resolution scans—is loaded into the console, exemplified by the WaveLight EX500 system, which processes the data to generate a personalized profile. The patient is then positioned under the and directed to fixate on a central target light for gaze stabilization, while the system's registration and high-speed eye tracker (operating at 1050 Hz) automatically detect and compensate for any cyclotorsion or minor movements to align the intraoperative eye position with the preoperative map. With the exposed, the delivers the customized pulses to reshape the , a process lasting 10 to 30 seconds per eye depending on the degree of correction required. The flap is subsequently repositioned without sutures, adhering naturally through the eye's own mechanisms, completing the intervention in approximately 10 minutes per eye. nomograms may be surgeon-adjusted to fine-tune parameters like spherical equivalent or based on clinical experience and patient-specific factors, including cyclotorsion effects.

Mechanism

Corneal Topography Mapping

Corneal topography mapping forms the foundational step in Contoura Vision, enabling highly personalized laser vision correction by capturing intricate details of the 's anterior surface. The procedure utilizes specialized diagnostic devices, such as the Wavelight Topolyzer VARIO, which employs advanced Placido-ring technology to perform non-contact scanning of the cornea. This system records over 22,000 elevation points across 22 measurement rings, providing a comprehensive dataset that exceeds the resolution of traditional methods. The mapping process begins with the projection of concentric Placido disc rings onto the corneal surface, where their reflected patterns are analyzed to reconstruct the cornea's curvature and elevation profile. This reflection-based technique generates a detailed 3D topographic map, highlighting subtle irregularities such as variations in elevation-based asphericity that deviate from the ideal prolate shape of the cornea. By quantifying these surface anomalies, the map serves as a blueprint for addressing corneal imperfections that contribute to visual distortions. A key aspect of this is its ability to differentiate between lower-order aberrations—primarily and errors stemming from overall refractive —and higher-order aberrations arising from localized corneal shape irregularities. Through precise analysis of the topographic data, the system identifies how these shape variations induce complex optical aberrations, allowing for targeted corrections. The maps encompass a diameter of 9-11 mm, extending beyond typical sizes to account for low-light (scotopic) conditions where peripheral corneal contributions to become significant. Unlike wavefront-guided approaches that sample approximately 200 points across the ocular system, Contoura 's provides far greater corneal-specific detail with its 22,000+ points.

Laser Ablation Process

The process in Contoura Vision employs the WaveLight EX500 , which operates at a 193 nm wavelength to photoablate corneal tissue through , breaking molecular bonds without thermal damage. This enables precise removal of stromal tissue in microlayers, typically 0.25 microns per pulse, to reshape the corneal curvature by flattening central areas for correction or steepening peripheral zones as needed for . The high repetition rate of 500 Hz allows for rapid treatment delivery, with eye-tracking at 1050 Hz ensuring accurate pulse placement despite minor eye movements. Topographic data from the corneal elevation map guides the ablation by feeding into proprietary software, such as the Contoura Vision algorithm integrated with the WaveLight system, which converts the 22,000-point topographic dataset into a personalized profile. This profile directs the to target irregularities, optimizing alignment with the visual axis—typically the corneal vertex—for enhanced refractive correction while reducing induced higher-order aberrations like or . The software employs to smooth uneven corneal surfaces, prioritizing lower depths in irregular areas to preserve overall corneal integrity. A distinctive element is the incorporation of topography-guided nomograms, which refine the profile by accounting for patient-specific variables including age, central corneal thickness, and baseline magnitude and axis, thereby tailoring the treatment to individual physiological factors. These nomograms, derived from clinical datasets like the FDA approval studies or proprietary adjustments (e.g., TMR or protocols), enable fine-tuning to achieve superior visual quality beyond standard spherical corrections.

Effectiveness

Clinical Outcomes

Clinical outcomes from the FDA approval trials for Contoura Vision, a topography-guided procedure, demonstrated high efficacy in achieving uncorrected (UCVA) targets. At 12 months post-operatively, 92.6% of treated eyes achieved 20/20 UCVA or better, while 65% reached 20/16 or better. Refractive accuracy is evidenced by metrics showing the mean spherical equivalent within 0.5 diopters (D) of the intended target in 98% of cases.

Quality of Vision Enhancements

Contoura Vision topography-guided achieves significant reductions in higher-order aberrations (HOAs), particularly vertical , resulting in enhanced and overall visual quality. In a clinical study of 60 eyes with and myopic , vertical decreased to 0.056 ± 0.030 μm at three months postoperatively, representing a statistically significant improvement over preoperative levels (P < 0.05), while minimizing induction of other HOAs compared to conventional methods. This reduction contributes to sharper image perception, especially in challenging lighting conditions. Post-2016 clinical investigations highlight substantial benefits for , with decreased halos and starbursts reported in the majority of patients. In the WaveLight System trials, only 6.4% of treated eyes experienced halos rated as "much worse" at six months postoperatively, reflecting a low persistence of these disturbances and improved satisfaction with low-light tasks like night driving. Patient-reported outcomes further indicate reduced and light sensitivity, with 98% of participants in a survey expressing willingness to undergo the procedure again due to these enhancements. A key advantage of Contoura Vision lies in its enhancement of functional vision, enabling 30-40% of patients to achieve "supernormal" outcomes better than 20/20 uncorrected . FDA approval trials demonstrated that over 30% of eyes attained uncorrected distance superior to preoperative best-corrected levels, often reaching 20/16 or better, which translates to heightened detail resolution in daily activities. This personalized correction of corneal irregularities fosters more natural, spectacle-free vision beyond standard acuity benchmarks. Recent analyses, including a 2023 non-randomized controlled trial, confirm improved low-light performance relative to baseline, with topography-guided treatments yielding better quality of vision scores and reduced aberrations in high-myopia cases. A 2025 prospective study of 50 subjects further demonstrated significant reductions in visual disturbances, with 70-98% reporting , halos, and starbursts as "never or rarely" occurring postoperatively (p < 0.0001 for key metrics), and overall satisfaction increasing by over 50 points. These findings underscore Contoura Vision's role in optimizing subjective visual comfort under dim illumination, supported by patient satisfaction rates exceeding 95% in several visual disturbance metrics.

Comparisons

With Wavefront-Guided LASIK

Contoura Vision, a topography-guided procedure, employs advanced to map over 22,000 unique elevation points on the surface, allowing for highly precise tailored to subtle corneal irregularities and shape variations. In comparison, wavefront-guided uses aberrometry to capture the eye's overall optical , typically measuring around 200 to 250 points across the entire visual pathway to correct higher-order aberrations from the , , and other ocular structures. This makes Contoura particularly effective for addressing corneal-specific irregularities, such as subtle elevations or depressions, whereas wavefront-guided excels in mitigating pure optical distortions not originating solely from the . Both techniques rely on lasers for tissue but diverge in customization depth, with Contoura's corneal-centric enabling more granular reshaping for irregular surfaces. Clinical studies show both procedures achieve high rates of 20/16 or better uncorrected , around 65-70%, with comparable outcomes overall.

With and PRK

Contoura Vision, as a topography-guided LASIK procedure, differs from (small incision lenticule extraction) in its approach to corneal and patient outcomes. While is a flapless that primarily corrects and myopic by extracting a lenticule through a small incision, Contoura Vision involves creating a corneal flap and uses detailed topographic mapping to address irregular corneas, offering enhanced suitability for patients with complex corneal shapes. A 2024 prospective contralateral study found that Contoura Vision provided faster visual recovery, with 89% of eyes achieving uncorrected distance (UDVA) of 20/16 or better at one week postoperatively, compared to 63% for eyes. However, carries a lower of postoperative eye due to its minimal disruption of corneal , as supported by meta-analyses showing reduced eye incidence in the first six months compared to variants. In terms of , Contoura Vision typically allows patients to resume activities within one day, contrasting with 's 3-7 day period for full visual stabilization, though both achieve comparable long-term efficacy with over 97% of eyes reaching 20/20 or better at . This quicker initial in Contoura Vision stems from its ablation process, which enables rapid epithelial healing under the flap. Suitability considerations favor Contoura Vision for individuals with topographic irregularities requiring precise customization, while SMILE is preferable for those in contact sports due to the absence of a flap, reducing risks of trauma-related complications. Compared to PRK (), Contoura Vision offers significantly faster healing and reduced discomfort, as PRK involves surface ablation without a flap, leading to epithelial regrowth over weeks and initial lasting 2-3 days. Patients undergoing Contoura Vision often report minimal and return to work within days, whereas PRK recovery can extend to 1-2 weeks for functional vision, with higher haze risk during healing. PRK remains suitable for patients with thinner corneas unsuitable for flap creation, avoiding potential flap-related issues in procedures like Contoura Vision. Overall, Contoura Vision prioritizes rapid recovery for eligible candidates, while PRK serves as an alternative for those with corneal limitations or high-risk lifestyles.

Risks and Recovery

Potential Side Effects

Contoura Vision, a topography-guided form of , carries potential side effects similar to other laser refractive surgeries, though clinical studies suggest reduced incidence of certain visual disturbances compared to standard due to its personalized corneal mapping. The most common is temporary dry eyes, affecting approximately 4% of patients requiring at three months post-surgery, with rates generally lower than in standard LASIK (up to 28% in general procedures); symptoms typically resolve within 3-6 months as nerve regeneration occurs. Mild halos and glare, often experienced during night driving, may occur post-surgery but at lower rates and severity than in wavefront-guided or standard LASIK, with improvements in visual symptoms reported in clinical trials (e.g., 23% mild halos at 12 months). In the pivotal FDA clinical trial for topography-guided LASIK (n=249 eyes), no cases of , , or flap complications were reported. Serious adverse events were minimal (1.6% transient best spectacle-corrected loss of ≥2 lines), with 98.4% patient satisfaction. General LASIK complications include flap-related issues, such as dislocation or epithelial defects, with an overall intraoperative complication rate ranging from 0.7% to 6.6%, though serious flap problems affect less than 1% of patients. , primarily microbial , are uncommon, occurring in 0.035% to 0.1% of procedures, and are managed promptly with antibiotics to prevent loss. , where the cornea thins and bulges, is exceedingly rare, with an incidence of 0.04% to 0.6% across refractive surgeries, and even lower in topography-guided procedures like Contoura Vision due to preoperative screening. Risk factors that may increase the likelihood or severity of side effects include pre-existing , which can prolong discomfort, and individual variations in corneal thickness or healing response. Overcorrection or undercorrection, potentially necessitating enhancement , occurs in about 2-3% of cases, though predictability is high with Contoura Vision's advanced . Overall, patient-reported outcomes indicate reduced dry eye symptoms and visual disturbances post-Contoura Vision compared to conventional .

Post-Operative Care

Following Contoura Vision surgery, patients typically receive prescriptions for and to prevent and reduce inflammation, which are administered multiple times daily for approximately one week. Protective shields are worn over the eyes at night for the first week to safeguard the corneal flap during sleep. Patients are instructed to avoid rubbing or touching the eyes to prevent displacement of the flap or other disruptions to healing. Monitoring begins with a follow-up appointment within 24 to 48 hours to assess initial healing and vision stability, followed by visits at one week, one month, and six months to evaluate refractive outcomes and corneal health. Refraction checks during these appointments help determine if enhancements are needed, typically considered only after stable measurements across at least two visits spaced three months apart. In the long term, patients should use UV-protective outdoors to shield the eyes from , and annual comprehensive eye exams are recommended to maintain overall ocular . Most individuals can resume within 1 to 2 days once clears sufficiently, while non-contact and strenuous activities may be restarted after 1 to 2 weeks, pending approval. The FDA advises using preservative-free for lubrication to manage potential dry eyes, which may persist for up to six months post-surgery.

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